NCT01765842

Brief Summary

Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

January 3, 2013

Last Update Submit

July 9, 2015

Conditions

Lupus Nephritis

Keywords

Lupus Nephritisremissionimmunosuppressive treatment

Outcome Measures

Primary Outcomes (1)

  • Rate of complete or partial response in lupus nephritis

    Complete response defined as: * Glomerular Filtration Rate (GFR)≥ 60, 73 m2 (or decline to baseline or ± 15% of baseline in those with GFR \<60 ml/min/1, 73m2). * Proteinuria ≤ 0.5 g/24 hours. * Inactive urine sediment (red cells, white cells, red cell casts according to local laboratory ranges). * Serum albumin\> 3 g / dl Partial response defined as: In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria \<3.5 gr/24 hours. * In patients with baseline proteinuria \<3.5 gr/24 hours, reduced proteinuria\> 50% of baseline. * In both situations, stabilization (± 25%) or reduce of the Glomerular Filtration Rate.

    Assessment at 12 months

Secondary Outcomes (4)

  • Renal function

    24 months of follow-up

  • Safety

    24 months of follow-up

  • Rescue medication

    24 months of follow-up

  • Efficacy

    24 months of follow-up

Study Arms (2)

Rituximab (1 cycle)

ACTIVE COMPARATOR

1 cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2

Biological: Rituximab

Rituximab (2 cycles)

EXPERIMENTAL

A second cycle of Rituximab First cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 Second cycle of Rituximab (4 i.v. infusions, 6 months later)

Biological: Rituximab

Interventions

RituximabBIOLOGICAL

Only one cycle of rituximab will be administered in this arm.

Also known as: Mabthera
Rituximab (1 cycle)Rituximab (2 cycles)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both men and women between 18 and 70 years.
  • Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year.
  • Informed consent form signed.

You may not qualify if:

  • Patients treated with rituximab in the previous years
  • Active/sepsis serious infections
  • Renal biopsy showing interstitial fibrosis and/or glomerular over 75%.
  • Known neoplasia
  • Heart failure with III/IV functional class
  • Pregnancy
  • Nursing
  • Known anaphylaxis to the product
  • History of hepatitis c
  • History of tuberculosis
  • Cardiovascular disease or uncontrolled hypertension
  • Chronic hepatitis B
  • Serious Cytopenia (granulocytes \< 500/mm3, further \< 10000/mm3)
  • Immunodeficiency (CVI, immunoglobulins deficiency)
  • Infection with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Cecilio Hospital

Granada, Granada, 18012, Spain

Location

Carlos Haya Hospital

Málaga, Málaga, 29010, Spain

Location

Virgen del Rocío, Hospital

Seville, Seville, 41013, Spain

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • María Jesús Castillo Palma, PhD

    Virgen del Rocío Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 10, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2015

Last Updated

July 10, 2015

Record last verified: 2013-01

Locations

ES(3)